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Inspection Troubles Hit Biocons Avastin Biosimilar

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FDA Inspection findings at Indias Biocon Biologics lead to a complete response letter on its BLA for a biosimilar version of bevac...

Inspection at Laurus Labs Ends in 2-item 483

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An FDA inspection of Indias Laurus Labs results in a Form 483 with two undisclosed observations.

Ethicon $10 Million Settlement Over Surgical Mesh

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Johnson & Johnsons Ethicon unit agrees to a $10 million settlement with Kentucky over alleged deceptive marketing practices involv...

Neonatal Neurodevelopmental Safety Study Guide

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FDA posts a draft guidance entitled Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.

ODAC Panel Backs Proposed Jemperli Studies

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An FDA advisory committee votes 8 to 5 that GlaxoSmithKlines proposals for two single-arm clinical trials of its Jemperli (dostarl...

New AI Tools Will Require FDA Flexibility: Califf

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FDA commissioner Robert Califf tells an Alliance for a Stronger FDA fireside chat that while new artificial intelligence advances ...

EUA for Cepheid Xpert Mpox Test

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FDA issues an emergency use authorization for the Cepheid Xpert Mpox test for use in a point-of-care setting for detecting monkeyp...

Pfizer Expanded Indication for Cibinqo in Adolescents

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FDA approves a Pfizer supplemental NDA for Cibinqo (abrocitinib), expanding its indication to include adolescents (12 to 18 years)...

FDA Withdrawals Emergent Narcan sNDA

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Federal Register notice: FDA withdraws the approval of an Emergent Biosolutions supplemental NDA for Narcan (naloxone hydrochlorid...

HHS Roadmap Outlines FDA Flexibilities Post-Covid

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An HHS Covid-19 Public Health Emergency Transition Roadmap outlines FDAs flexibilities and actions that will not be affected after...